The BELIEF trial was an international study of belinostat in patients with relapsed or refractory (R/R) peripheral T-cell lymphoma (PTCL) that led to FDA-approval for the disease. Herein, we present a subset analysis of patients with angioimmunoblastic T-cell lymphoma (AITL).
Patients with R/R PTCL received belinostat 1000mg/m2 intravenously every 21 days. The primary study endpoint was ORR by Cheson 2007 criteria. Secondary endpoints included duration of response (DOR), progression-free survival (PFS), and overall survival (OS).
Of 129 patients treated, 22 patients were diagnosed with AITL. The ORR for AITL patients was 45.5%, with 18% achieving compete response. After a median follow up of 21.5 months, the median DOR, PFS, and OS were 13.6 months, 4.2 months, and 9.2 months, respectively. Common grade 3/4 adverse events were asthenia, fatigue, cytopenias, and septic shock.
Single-agent belinostat induces clinically meaningful duration of response in patients with AITL and warrants further investigation in studies.